Neolight

FDA UDI

Class II (US FDA UDI)

by Neolight Llc

Identity

Trade Name: Neolight FDA UDI
Generic Name: Ophthalmic fundus camera FDA UDI
Device Name: ICON Cart Control Box FDA UDI
Model / Reference: PCI 40-1003 FDA UDI
Description: ICON Cart Control Box FDA UDI

Identifiers

Primary DI / UDI-DI: 00852788008019 FDA UDI
510(k) Number: K223575 FDA UDI
FDA Product Code: HKI FDA UDI
GMDN Term: Ophthalmic fundus camera FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 886.1120 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Ophthalmic fundus camera

Neolight by Neolight Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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RetCam 3 — Natus Medical, Inc. · Class II
Volk Pictor VP1ANT — VOLK OPTICAL INC. · Class II
VISUCAM 224 — Carl Zeiss Meditec AG · Class II
NON-MYDRIATIC RETINAL CAMERA TRC-NW400 — Topcon Corp. · Class II

Cleared under the same submission

K223575 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Neolight Llc

Sources (1)

FDA UDI 3af8a5a2-ebe2-437d-98de-aa8f7001c37a 34 fields · synced May 30, 2026